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Maxillary sinus floor augmentation with autogenous bone and bovine bone mineral in the resorbed maxilla: a 1-year multicentre, split-mouth, randomized clinical trial


- candidate number27900
- NTR NumberNTR6686
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2017
- Secondary IDsMEC 2017-001 NL59578.078.16
- Public TitleMaxillary sinus floor augmentation with autogenous bone and bovine bone mineral in the resorbed maxilla: a 1-year multicentre, split-mouth, randomized clinical trial
- Scientific TitleMaxillary sinus floor augmentation with autogenous bone and bovine bone mineral in the resorbed maxilla: a 1-year multicentre, split-mouth, randomized clinical trial
- ACRONYMCerabone Study
- hypothesisThe succes of dental implants placed in the augmented maxillary sinus by using a bovine bone mineral (BBM) with some locally harvested AB chips, is superior to, implants placed in augmented sinuses with solely autogenous bone.
- Healt Condition(s) or Problem(s) studiedMaxillary sinus, Sinus floor elevation, Oral implants, Autogenous bone, Bovine bone material
- Inclusion criteria-18 years and older
-In need for bilateral dental implant placement in the posterior maxilla
-Bone height should be more then 2 mm and less then 5 mm
-Bone width should be over 5 mm
-Enough volume of the mandibular ramus to facilitate bone harvesting.
- Exclusion criteriaPresence of clinical active periodontal disease
Acute inflammatory oral disease
Smoking
Uncontrolled diabetes
A history of radiotherapy in the head- and-neck region or current chemotherapy
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-aug-2017
- planned closingdate1-jan-2021
- Target number of participants46
- InterventionsThe study will be designed as a multicenter, split-mouth, randomized split mouth study.: Randomisation will be carried out between two sides:
1. AB harvested from mandibular ramus
2. BBM, Cerabone (Cerabone, Botiss Dental, Berlin, Germany) mixed with approximately one-fifth locally harvested AB chips (via existing incision for sinus elevation).
- Primary outcomeSuccess of the MSFA procedure determined by 1-year clinical performance of dental implants placed in augmented maxillary sinus
- Secondary outcome-Volumetric changes of the bone graft
-Histological evaluation
-Micro-computed tomography (μCT) analysis
-Patient satisfaction and pain scores regarding MSFA
-Implant survival
-Implant success
-Prosthetic success
-Complications
-Plaque, gingival and bleeding indices
-Pocket probing depth
-Peri-implant radiographic bone levels
-Volumetric changes of the bone graft
-Patients satisfaction with implant placement and prosthesis
- TimepointsIntake, MSFA procedure, check up after two weeks, implant placement procedure, check up after two weeks, second-phase surgery, 1 month after placement of final prosthesis, 1 year after placement of final prosthesis
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES B.P. Jonker
- CONTACT for SCIENTIFIC QUERIES B.P. Jonker
- Sponsor/Initiator Erasmus Medical Center, St. Anna Hospital, Catharina Hospital Eindhoven, St. Antonius Hospital
- Funding
(Source(s) of Monetary or Material Support)
Straumann AG, Basel, Switzerland
- PublicationsN/A
- Brief summaryInsufficient bone height is a common problem in the reconstruction of the edentulous posterior maxilla prior to the placement of dental implants. To create sufficient height, maxillary sinus floor augmentation (MSFA) is performed with autogenous bone (AB) or bone substitutes, such as bovine bone mineral (BBM). AB is considered the golden standard, but has major drawbacks such as fast resorption, limited availability and considerable morbidity at the donor side. BBM might perform better then AB, but there is a lack of randomized controlled trials.

A bilateral MSFA will be performed in 46 patients with a resorbed posterior maxilla. MSFA will be performed randomly with AB harvested from mandibular ramus on one side and with BBM, mixed with some locally harvested AB chips (via existing incision for sinus elevation) on the other side.
Implant placement will be performed 4-6 months after augmentation. Second-phase surgery and implant loading will be performed 4-6 months thereafter.

The aim of this study is to assess the success of MSFA determined by 1-year clinical performance of dental implants placed in augmented maxillary sinus with solely AB versus BBM with some locally harvested AB chips.
- Main changes (audit trail)
- RECORD9-sep-2017 - 16-sep-2017


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